Overview
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics profiles of TG-1000 in healthy volunteers, and to evaluate the food effect on pharmacokinetics of single oral dose of TG-1000 in healthy volunteers.
Description
This is a phase 1, single-center, randomized, double-blind, placebo-controlled, single-dose escalation study to evaluate the safety, tolerability, and pharmacokinetics profiles of TG-1000 in healthy volunteers, and to evaluate the food effect on pharmacokinetics of single oral dose of TG-1000 in healthy volunteers. The study will be divided into two parts.
Part A is designed as randomized, double-blind, placebo-controlled, sequential, single ascending oral dose to evaluate the safety, tolerability, and PK profiles of TG-1000 in healthy volunteers.
Part B is designed as randomized, open-label, two treatment (fasted vs. fed), two-period, two-sequence crossover to compare the effects of food on the PK of single oral dose of TG-1000 in healthy subjects.
Eligibility
Inclusion Criteria:
- Willing to provide written informed consent.
- Age 18 (or legal adult age) to 45 years.
- Body mass index (BMI) in the range of 19.0 to 24.0 kg/m2 and body weight 50 kg for male and 45 kg for female at Screening.
- Subjects have good communication with Investigator and agree to follow the study requirement to complete study.
Exclusion Criteria:
- Clinically significant abnormality in 12-lead ECG, chest X-ray, abdominal ultrasounds, physical examination, vital signs or laboratory values at Screening or Day-1.
- Positive breath alcohol or urine drug tests at Day-1.
- Positive test results for IgM anti-HAV antibody, HBsAg, anti-HCV antibody, HIV or syphilis at Screening.
- Female subjects with positive pregnancy test results at Screening or Day-1.
- Male subjects are unwilling to use effective contraception and refrain from sperm donation from Screening until 3 months after the study drug administration.
- Current or prior history of any of the following:
- Significant cardiac disease, diabetes, liver, kidney disease, psychiatric diseases or drug abuse or diseases that will affect immunity.
- Difficulty in swallow or gastrointestinal disorder that could interfere with the absorption of the study drug
- Difficulty in blood sampling or venipuncture
- Drug allergy or hypersensitivity
- Blood donation 400mL within 3 months before and after study.
- Alcoholics or frequent drinkers prior to Screening.
- Frequent smokers prior to Screening.
- Use of any prohibited medications or surgeries prior to study drug administration:
- Received any other investigational agents or devices, liver enzyme inducer or inhibitors, medications including prescriptions, non-prescriptions or herbal remedies, dietary supplements or surgeries.
- Unwilling to abstain from alcohol, tobacco, nicotine containing products, caffeine- or xanthine-containing beverages from Screening until discharge from the phase I unit.
- Subjects may not be qualified for the study judged by the Investigator.